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About the Role

Entry level role into clinical research that provides administrative and technical support. Supports audit readiness by ensuring files are reviewed according to the organization's SOP and department guidance. Aids the development of the critical path for site activation within assigned projects to support rapid site activations. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists suitable for feasibility activities and provide local input into the site tiering process.

Responsibilities

Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
Performs administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, providing documents and reports to internal team members.
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
Maintains vendor trackers.
Supports start-up team in Regulatory submissions.
Works directly with sites to obtain documents related to site selection.
Works in collaboration with teammates to achieve targeted goals for assigned projects.
Connect with the team and appropriate clinical personnel regarding site issues and risks.

Requirements

Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Ability to work in a team or independently as required.
Flexibility to reprioritize workload to meet changing project timelines.
Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
Good English language and grammar skills and proficient local language skills as needed.
Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
Effective oral and written communication skills.
Crucial judgment and decision-making skills.
Capable of accurately following project work instructions.
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel.
Australian citizenship or permanent residency required.

Skills

MS Office (Word, Excel, and PowerPoint)
Clinical trial database systems
Oral and written communication
Judgment and decision-making

Location

Sydney
Brisbane
Melbourne
Adelaide

Work Type

Home-based
Standard (Mon-Fri)

Experience Level

Entry level
0 to 1 year

Education Level

Bachelor's degree

Benefits

Comprehensive benefits
Wellness programs
Employee Assistance Program
Flexible arrangements
Generous leave policies
Option to purchase additional leave
Paid birthday leave
Company paid parental leave
Paid volunteer time
Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning
Workshops
Mentorship programs

About the Company

Thermo Fisher Scientific values the health and wellbeing of our employees.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Thermo Fisher Scientific is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
WGEA Employer of Choice for Gender Equality